BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUIET PLEASE EP

    MDR report key: 14279580 · Received May 4, 2022

    Report

    Report Number
    0002183416-2022-00002
    Event Type
    Injury
    Date Received
    May 4, 2022
    Date of Event
    January 28, 2022
    Report Date
    May 3, 2022
    Manufacturer
    APOTHECARY PRODUCTS LLC
    Product Code
    EWD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2022, THE COMPANY WAS AWARE THAT THE REPORT WAS NOT VISIBLE IN MAUDE DATABASE. AFTER ENQUIRING WITH FDA CDRH EMDR REPRESENTATIVE, WE LEARNED THERE WAS A TECHNICAL PROBLEM WHILE SUBMITTING THE FILE. THE COMPANY WAS ADVISED TO RESUBMIT THIS FORM AND TO ADD THIS STATEMENT. APOTHECARY PRODUCTS LLC, QUALITY TEAM HAS DONE FURTHER RESEARCH ON ITEM 69018 FLENTS QUIET PLEASE EAR PLUGS AND THIS APPEARS TO BE AN ISOLATED INCIDENT WHERE USER POTENTIALLY HAD LATEX ALLERGIC REACTION. THE ITEM IS NOT MADE WITH NATURAL RUBBER LATEX. OUR EAR PLUGS ARE MADE OF PVC MATERIAL. WE CONTACTED OUR CONTRACT MANUFACTURERS TO SEE IF LATEX WAS USED IN ANY STEPS OF HANDLING THE DEVICE, AND THE ANSWER WAS NO. ALL THE STEPS INVOLED IN MANUFACTURING AND PACKAGING OF THIS DEVICE ARE DONE WITH GLOVES WHICH ARE NOT MADE WITH NATURAL RUBBER LATEX, OUR DEVICE DOES NOT HAVE LATEX..

    Description of Event or Problem · 0

    CUSTOMER USED ONE PAIR OF THE EAR PLUGS FOR SLEEPING. SHE DEVELOPED THE ALLERGY. WHEN SHE WOKE UP BOTH EARS WERE SWOLLEN INSIDE THE EAR CANAL, PARTICULARLY THE INSIDE RIGHT EAR. SHE IS ALLERGIC TO LATEX BUT THIS ITEM SAYS "NOT MADE WITH NATURAL RUBBER LATEX.." CALLED DOCTOR AND HE PRESCRIBED ANTIBIOTIC EAR DROPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1822894 QUIET PLEASE EP EAR PLUGS EWD APOTHECARY PRODUCTS LLC 69018

    Patients

    Seq Age Sex Outcome Treatment
    1 Female